Aid, methods of using the same, and kits thereof

ABSTRACT

Disclosed herein is an aid for inducing a physiologically desirable movement. The aid comprises upper and lower surfaces, defining therebetween a thickness of the aid. The aid also comprises a plurality of protrusions extending from the upper surface of the aid and capable of engaging a body portion of a user for inducing discomfort in the body portion. Also disclosed herein are methods of using the aid to induce the physiologically desirable movement in a subject in need thereof and kits including one or more aids.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Prov. App. No. 61/679,855, filed Aug. 6, 2012, and U.S. Prov. App. No. 61/831,882, filed Jun. 6, 2013, all of which are hereby incorporated by reference.

TECHNICAL FIELD

The present invention relates to aids for inducing a physiologically desirable movement, to methods for inducing the physiologically desirable movement, and to kits of the aids.

BACKGROUND

Aids are typically used to support a user's body or a portion thereof (e.g., the user's foot) while the user is moving (e.g., walking, running, etc.) or at rest (e.g., standing, sitting, lying down, etc.). Some aids, such as an insole, include a supporting material such as a foam or gel, or a supporting structure such as bumps or protrusions, to provide support to the user's sole. Such insoles often provide a feeling of comfort to the user, and thus, do not motivate or prompt the user to alter their movement or posture.

SUMMARY

The present invention is directed to an aid for inducing a physiologically desirable movement. The aid comprises upper and lower surfaces, defining therebetween a thickness of the aid. The aid also comprises a plurality of protrusions extending from the upper surface of the aid and capable of engaging a body portion of a user for inducing discomfort in the body portion.

The protrusions may have a shape selected from the group consisting of a pyramidal shape, a spherical shape, a circular shape, an elliptical shape, a trapezoidal shape, a cylindrical shape, a rectangular shape, a square shape, a conical shape, and an irregular shape. The protrusions may have a height of about 2 mm to about 10 mm. The thickness of the aid may be uniform. The thickness of the aid may be about 1 mm to about 10 mm. The aid may be selected from an insole, a back pad, and a butt pad.

The aid may be an insole including a toe end and a heel end, defining therebetween a length dimension of the insole. The protrusions may be arranged in rows extending at least partially in the length dimension of the insole. A first of the protrusions may be spaced from a second of the protrusions, defining therebetween a distance. The distance may be about 10 mm. The insole may be adaptable to be positioned in footwear. The footwear may be selected from the group consisting of a sandal, a shoe, and a sock.

The body portion may be a foot of the user. A hallux and a heel of the foot may define therebetween a length dimension of the foot. The length dimension of the insole may be substantially equivalent to the length dimension of the foot of the user.

Each protrusion may include a distal end located opposite the upper surface of the aid and have a cross-sectional shape with a first area. Each protrusion may also include a proximal end located adjacent to the upper surface of the aid and have a cross-sectional shape with a second area. The first area may be smaller than the second area. Each protrusion may be conical with an apex located opposite the upper surface of the aid. The apex may be engageable with the body portion of the user.

The present invention is also directed to a method for treating a subject suffering from gait asymmetry. The method comprises providing an insole. The insole includes upper and lower surfaces, defining therebetween a thickness of the insole. The insole also includes a toe end and a heel end, defining therebetween a length dimension of the insole. The insole further includes a plurality of protrusions extending from the upper surface of the insole. The protrusions are engagable with a body portion of the subject for inducing discomfort in the body portion. The method also comprises contacting the body portion of the subject with the insole for a period of time sufficient to modify the gait of the subject.

The subject may have had a stroke. The stroke may be a unilateral stroke. The body portion may be a non-paretic sole of the subject. The protrusions may extend from at least one of a toe region, an arch region, and a heel region of the insole. The period of time may include a plurality of discrete time periods. The method may further comprise positioning the insole in footwear of the subject. The footwear may be selected from the group consisting of a sandal, a shoe, and a sock.

The method may further comprise replacing the insole with a second insole. The second insole may include upper and lower surfaces, defining therebetween a thickness of the second insole. The second insole may also include a toe end and a heel end, defining therebetween a length dimension of the second insole. The second insole may further include a plurality of protrusions extending from the upper surface of the second insole. The protrusions of the second insole may be engagable with the body portion of the subject for inducing discomfort in the body portion. The method may also include contacting the body portion of the subject with the second insole for a period of time sufficient to modify the gait of the subject. The protrusions of the second insole may have a height greater than a height of the protrusions of the first insole.

The present invention is further directed to a method for inducing a physiologically desirable movement. The method comprises providing the above described aid, and contacting a first body portion of the subject with the aid for a period of time sufficient to modify the movement of the subject. The first body portion may be contralateral to a second body portion to which weight is to be shifted.

The subject may be suffering from at least one of a musculoskeletal impairment and a neurological impairment. The neurological impairment may be selected from the group consisting of a stroke and a unilateral stroke. The neurological impairment may be a unilateral stroke. The first body portion may be a non-paretic body portion of the subject.

Contacting may include positioning the protrusions adjacent to the first body portion of the subject. The period of time may include a plurality of discrete time periods.

The present invention is also directed to a kit. The kit comprises a plurality of insoles. Each insole may include upper and lower surfaces, defining therebetween a thickness of the respective insole. Each insole may also include protrusions extending from the upper surface and engageable with a body portion of a subject for inducing discomfort in the body portion.

The aid may be an insole comprising a toe end and a heel end, defining therebetween a length dimension of the insole. A height of the protrusions of a first insole may be smaller than a height of the protrusions of a second insole. The thickness of a first insole may be smaller than the thickness of a second insole. The length dimension of a first insole may be substantially equivalent to the length dimension of a second insole. The subject may have had a stroke. The body portion may be a non-paretic body portion of the subject. The protrusions of a first aid may be arranged in a first pattern and the protrusions of a second aid may be arranged in a second pattern. The first and second patterns may be substantially different from one another. The insoles may be adaptable to be positioned in footwear. The footwear may be selected from the group consisting of a sandal, a shoe, and a sock.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an insole in accordance with one embodiment of the invention.

FIG. 2 is a side view of the insole of FIG. 1.

FIG. 3 is a perspective view of an insole in accordance with another embodiment of the invention.

FIG. 4 is a perspective view of an insole in accordance with yet another embodiment of the invention.

FIG. 5 is a perspective view of an insole in accordance with another embodiment of the invention.

FIG. 6 is a perspective view of an insole in accordance with yet another embodiment of the invention.

FIG. 7 is a perspective view of an insole in accordance with another embodiment of the invention.

FIG. 8 shows the static weight bearing of the subjects while standing with and without the insole. Weight bearing is shown as a percentage of the body weight applied to the left and right feet. Mean±standard deviation (SD) are shown.

FIG. 9 shows the latencies for the right and left limbs or sides during large backward translations, in which the following conditions were tested: no insole was used (i.e., no insole), the insole was placed in the right sandal (i.e., right insole), and the insole was placed in the left sandal (i.e., left insole). Mean±standard deviation (SD) are shown.

FIG. 10 shows the (A) single support, (B) swing, and (C) stance time as calculated as a percentage of the gait cycle for the left and right limbs or sides, in which the following conditions were tested: no insole was used (i.e., no insole), the insole was placed in the left sandal (i.e., left insole), and the insole was placed in the right sandal (i.e., right insole). Mean±standard deviation (SD) are shown.

FIG. 11 shows the single support time as calculated as a percentage of the gait cycle for the left and right limbs or sides before and after the treatment sessions. The condition tested was no insole being placed in the subject's sandals.

DETAILED DESCRIPTION

The present invention relates to an aid for inducing a physiologically desirable movement or altering an established pattern of movement in a user of the aid. Such movement may include transferring or shifting weight from a first or target body portion of the user to a second or contralateral body portion of the user. The aid may include multiple protrusions that induce discomfort in the target body portion of the user, thereby causing the user to shift weight from the target body portion to the contralateral body portion to avoid the discomfort. Accordingly, the user may alter movement of the target and contralateral body portions relative to one another to alleviate the discomfort, and therefore, the user is induced to move in the physiologically desired manner. The aid may be an insole for treating gait asymmetry in the user or subject, in which the physiologically desirable movement may be improved gait symmetry.

The present invention also relates to methods for inducing the physiologically desirable movement in the subject. Such methods may include contacting the first or target body portion of the subject with the aid for a period of time sufficient to modify the movement of the subject. Contacting may include positioning the protrusions adjacent to the first or target body portion of the subject.

The present invention further relates to kits for use with the methods. The kits may include multiple aids. Any number of parameters or features of the aids may vary between each aid, for example, a height of the protrusions, a thickness of the aid, a length dimension of the aid, an arrangement or pattern of the protrusions, and combinations thereof

1. DEFINITIONS

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In case of conflict, the present document, including definitions, will control. Preferred methods and materials are described below, although methods and materials similar or equivalent to those described herein can be used in practice or testing of the present invention. All publications, patent applications, patents and other references mentioned herein are incorporated by reference in their entirety. The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting.

The terms “comprise(s),” “include(s),” “having,” “has,” “can,” “contain(s),” and variants thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that do not preclude the possibility of additional acts or structures. The singular forms “a,” “and” and “the” include plural references unless the context clearly dictates otherwise. The present disclosure also contemplates other embodiments “comprising,” “consisting of” and “consisting essentially of,” the embodiments or elements presented herein, whether explicitly set forth or not.

Discomfort may be a sensation in which a subject experiences a provocation of sensory receptors and/or nerves in the region of the body that is in contact with the herein described aid or insole. The discomfort may range from mild distress to pain. The discomfort may bring about a response by which the body attempts to avoid or protect itself from the discomfort and results in a physiologically desirably movement, which may be a shift in body balance, a shift in weight, and/or a repositioned posture, for example.

For the recitation of numeric ranges herein, each intervening number there between with the same degree of precision is explicitly contemplated. For example, for the range of 6-9, the numbers 7 and 8 are contemplated in addition to 6 and 9, and for the range 6.0-7.0, the number 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, and 7.0 are explicitly contemplated.

2. AID

Provided herein is an aid for inducing a physiologically desirable movement or altering an established pattern of movement or posture in a user of the aid. Such movement may include transferring or shifting weight from a first or target body portion of the user to a second or contralateral body portion of the user.

The aid includes upper and lower surfaces, defining therebetween a thickness of the aid. The thickness of the aid may be uniform or variable. The thickness of the aid may be about 1 mm to about 20 mm. In other embodiments, the thickness of the aid may be about 1 mm to about 10 mm. In still other embodiments, the thickness of the aid may be about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm.

The aid also includes a plurality of or multiple protrusions extending from the upper surface of the aid. Such protrusions are capable of contacting or engaging the target body portion of the user when the target body portion exerts a force (e.g., a weight of the body portion or a weight of the user's body) against the protrusions. In turn, the protrusions impinge upon or depress the target body portion of the user, thereby inducing discomfort in the target body portion of the user. Accordingly, the discomfort prompts or motivates the user to shift weight from the target body portion to the contralateral body portion, thereby altering how the user moves or positions the target and contralateral body portions relative to one another.

The aid may have any number of shapes including, but not limited to, square, rectangular, triangular, elliptical, circular, and irregular. The shape of the aid may correspond to a shape or outline of the target body portion. In a non-limiting example, if the target body portion is a foot of the user, the aid may have a shape corresponding to the shape or outline of a foot. In other embodiments, the shape of the aid may correspond to a portion of the shape or outline of the target body portion, for example, but not limited to, a shape corresponding to the shape or outline of a toe region of the foot.

a. Protrusions

The aid may comprise multiple protrusions extending from the upper surface thereof. The protrusions can be evenly distributed across the upper surface of the aid. In other embodiments, the protrusions may be unevenly distributed across the upper surface of the aid or distributed in a specific region of the upper surface of the aid. The specific region may correspond to where in the target body portion discomfort is to be induced.

The protrusions may have any number of shapes including, but not limited to, pyramidal, conical, spherical, half-spherical, circular, elliptical, cylindrical, trapezoidal, rectangular, square, or irregular. The protrusions may be arranged in any number of patterns including, but not limited to, a rectangular or square pattern (i.e., columns and rows), a concentric or circular pattern, a triangular pattern, and a random pattern. In other embodiments, a first of the protrusions may be spaced apart from a second of the protrusions, thereby defining a distance D between the first and second protrusions. The distance D may be about 1 mm to about 20 mm. Alternatively, the distance D may be about 5 mm to about 15 mm. In still other alternative embodiments, the distance D may be about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, or about 15 mm. The distance D may be about 10 mm.

Each protrusion may have a height relative to the upper surface of the insole. The height of each protrusion may be about 2 mm to about 10 mm. In other embodiments, the height of each protrusion may be about 2 mm to about 5 mm. In still other embodiments, the height of each protrusion may be about 2 mm, about 3 mm, about 4 mm, or about 5 mm.

Each protrusion may have a distal end located opposite of the upper surface of the aid. The distal end may have a first cross-sectional shape having a first area. Each protrusion may also have a proximal end located adjacent to the upper surface of the aid. The proximal end may have a second cross-sectional shape having a second area. The first area may be smaller than the second area. In other words, the second area may be larger than the first area.

In other embodiments, each protrusion may be conical with an apex located opposite the upper surface of the aid (i.e., at the distal end of the protrusion). The apex of the protrusion may be engageable with the target body portion of the user to induce discomfort in the target body portion of the user as described above. The apex of the distal end of the protrusion may have an area that is contactable with the target body portion (i.e., a contact area). The contact area is a portion of the apex that is in direct contact with the target body portion of the user. In some embodiments, the contact area may be about 0.1% to about 50% of a total surface area of the protrusion. In other embodiments, the contact area may be about 0.1% to about 40% of the total surface area of the protrusion. In still other embodiments, the contact area may be about 0.1% to about 30% of the total surface area of the protrusion. In some embodiments, the contact area may be about 0.1% to about 20% of the total surface area of the protrusion. In other embodiments, the contact area may be about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, about 15%, about 16%, about 17%, about 18%, about 19%, or about 20% of the total surface area of the protrusion.

b. Body Portion

(1) Foot

The aid may contact or engage the target body portion of the user. The target body portion may be a foot of the user. Particularly, the target body portion may be a sole of the user's foot, and therefore, the aid may have a shape generally corresponding to a shape of the user's sole or a portion thereof. Accordingly, the aid may be an insole as illustrated in FIGS. 1 and 2.

(a) Insole

With reference to FIGS. 1 and 2, the insole 1 has generally rounded edges 4, and a toe end 8 and a heel end 12, defining therebetween a length dimension L of the insole 1. In some embodiments, the length dimension L may be substantially equivalent to a length dimension of the user's foot, in which the length dimension of the user's foot is defined by a hallux and a heel of the user's foot. In other embodiments, the length dimension L of the insole 1 may be smaller or greater than the length dimension of the user's foot. The insole 1 also includes lower and upper surfaces 16, 20, defining therebetween a thickness T of the insole 1 (FIGS. 1 and 2). The lower surface 16 of the insole 1 is generally flat or smooth. In the illustrated construction, the thickness T of the insole 1 decreases along the length dimension L from the heel end 12 towards the toe end 8 of the insole 1. Alternatively, the thickness T of the insole 1 may vary in any number of ways along the length dimension L of the insole 1. For example, the thickness T may increase along the length dimension L of the insole 1 from the heel end 12 towards the toe end 8 of the insole 1, or the thickness T may be uniform along the length dimension L of the insole 1. The thickness T may be about 1 mm to about 20 mm. In other embodiments, the thickness T may be about 1 mm to about 10 mm. In still other embodiments, the thickness may be about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, or any combination thereof when the thickness T is variable along the length dimension L of the insole 1.

With continued reference to FIGS. 1 and 2, multiple protrusions 24 extend from the upper surface 20 of the insole 1, and each protrusion 24 has a height H relative to the upper surface 20 of the insole 1. As described above, the height H of each protrusion 24 may be about 2 mm to about 10 mm. In other embodiments, the height H of each protrusion 24 may be about 2 mm to about 5 mm. In still other embodiments, the height H of each protrusion 24 may be about 2 mm, about 3 mm, about 4 mm, or about 5 mm.

The protrusions 24 are arranged in rows 28 extending at least partially in the length dimension L of the insole 1. Particularly, the protrusions 24 are distributed across the upper surface 20 of the insole 1 in rows 28 and columns 32, thereby defining a square pattern (FIG. 1). Alternatively, and as described above, the protrusions 24 may be arranged in any number of patterns. In other embodiments, a first of the protrusions 24 may be spaced apart from a second of the protrusions 24, thereby defining a distance D between the first and second protrusions 24 (FIG. 2). The distance D may be about 1 mm to about 20 mm. Alternatively, the distance D may be about 5 mm to about 15 mm. In still other alternative embodiments, the distance D may be about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, or about 15 mm. The distance D may be about 10 mm.

In other embodiments, the protrusions 24 may be distributed across a first region 36 of an insole 101 corresponding to the toes of the user's foot (i.e., a toe region 36 of the insole 101) as illustrated in FIG. 3. In still other embodiments, the protrusions 24 may be distributed across a second region 40 of an insole 201 corresponding to a medial arch of the user's foot (i.e., a medial arch region 40 of the insole 201) as illustrated in FIG. 4. In yet still other embodiments, the protrusions 24 may be distributed across a third region 44 of an insole 301 corresponding to a lateral arch of the user's foot (i.e., a lateral arch region 44 of the insole 301) as illustrated in FIG. 5. In other embodiments, the protrusions 24 may be distributed across a fourth region 48 of an insole 401 corresponding to a heel of the user's foot (i.e., a heel region 48 of the insole 401) as illustrated in FIG. 6.

The protrusions 24 may also be distributed across the toe, medial arch, lateral arch, and heel regions 36, 40, 44, 48 of the insole 1, 101, 201, 301, 401, and any combination thereof. For example, the protrusions may be distributed across the toe, medial arch, lateral arch, and heel regions of the insole. In other embodiments, the protrusions may be distributed across the toe, medial arch, and lateral arch regions of the insole; the toe, medial arch, and heel regions of the insole; the toe, lateral arch, and heel regions of the insole; or the medial arch, lateral arch, and heel regions of the insole. In still other embodiments, the protrusions may be distributed across the toe and medial arch regions of the insole; the toe and heel regions of the insole; the toe and lateral arch regions of the insole; the lateral arch and heel regions of the insole; the medial arch and lateral arch regions of the insole; or the medial arch and heel regions of the insole.

In operation, the insole 1 is adaptable to be placed or positioned in the user's footwear, for example, a sandal, a shoe, a sock, and the like. Alternatively, the insole 1 may include one or more fasteners (e.g., straps with hook and loop fasteners, buckles, etc.) for attaching the insole 1 to the user's foot. Particularly, the lower surface 16 of the insole 1 is located opposite of the sole of the user and adjacent to the footwear. The upper surface 20 of the insole 1 is placed or positioned adjacent to the sole of the user, and thus, the protrusions 24 are positioned adjacent to the user's sole. Accordingly, when the user places a force (e.g., a load or weight) on a sole contacting the upper surface 20 of the insole 1, and thus the protrusions 24, the user feels discomfort because the protrusions 24 impinge upon or depress the sole of the user. In other words, the protrusions 24 are substantially not deformed by the weight of the user, and therefore, push (or exert a counter force) against the sole of the user when the user places weight on the sole in contact with the insole 1. To avoid such discomfort, the user may shift their weight to a sole not in contact with the insole 1, i.e., the sole contralateral to the sole in contact with the insole 1, and therefore, the insole 1 has affected an altered movement in the user. The insoles 101, 201, 301, 401 operate in a similar manner as described above for the insole 1.

(b) Insole with Roller

FIG. 7 illustrates another embodiment of the insole. In this embodiment, an insole 501 includes a roller 52 positioned adjacent to the lower surface 16 of the insole 501. Particularly, the roller 52 is located adjacent to a discrete region 56 of the insole 501. In the illustrated construction, the discrete region 56 is a region between the toe, medial arch, and lateral arch regions 36, 40, 44 of the insole 501. Alternatively, the discrete region 56 may correspond to the toe region 36 of the insole 501, the medial arch region 40 of the insole 501, the lateral arch region 44 of the insole 501, the heel region 48 of the insole 501, or any region of the insole 501 located between the aforementioned regions of the insole 501. The roller 52 may have a cylindrical shape and extend beyond first and second edges 60, 64 of the insole 501. In an alternative construction, the roller 52 may extend between, but not beyond, the first and second edges 60, 64 of the insole 501.

The insole 501 operates in identical fashion as the insole 1 shown in FIGS. 1 and 2 and described above. The roller 52, however, alters or adjusts how the upper surface 20 of the insole 501, and thus the protrusions 24, contact or engage the sole of the user. When the user places weight on the sole contacting the insole 501, the weight is distributed differently across the upper surface 20 of the insole 501 as compared to in the absence of the roller 52, and therefore, the user feels an uneven distribution of discomfort across the sole in contact with the insole 501. Accordingly, the user is prompted or motivated to alter how weight is distributed across the upper surface 20 of the insole 501, in addition to shifting their weight to a sole not in contact with the insole 501, i.e., the sole contralateral to the sole in contact with the insole 501, to avoid the discomfort caused by the insole 501.

(c) Insole with Sensor

The induction of a physiologically desirable movement may be monitored with a sensor fixedly coupled to the aid. Accordingly, in an embodiment, this invention is a system for monitoring a physiologically desirable movement of a subject, comprising an aid, a sensor, and a signal processor. The aid may have an insole as described herein. The sensor may be fixedly coupled to the insole, for example, to the toe region of the insole, the medial arch region of the insole, the lateral arch region of the insole, the heel region of the insole, to the upper surface of the insole, to the lower surface of the insole, between the upper and lower surfaces of the insole, or any combination thereof.

The sensor is configured to measure a signal representative of the physiological parameter during walking, running, standing, pedaling, or lying down, for example. The signal processor is operatively coupled to the sensor and configured to determine a diagnosis based on the measured signal. An alert may be generated in response to the diagnosis substantially in real time.

The sensors may include force sensors. As explained below, each sensor may be coupled to an aid (e.g., an insole described herein) and configured to measure a signal representative of a physiological parameter during walking, running, standing, or lying down, for example. In some embodiments, the sensors may be configured to measure signals representative of physiological parameters comprising at least one of weight, spine alignment, posture, and muscle group use. In other embodiments, the sensors may be configured to measure signals representative of other physiological parameters. Any force or pressure sensor known in the art may be used so long as the sensor is capable of reliably measuring a signal representative of a physiological parameter during movement and/or rest. In some embodiments, force is measured and reported, while in other embodiments, pressure is calculated by the formula P=F/A, where P is pressure, F is force, and A is the area (e.g., area of a sensor over which the force F is applied). One example of a suitable sensor is a FLEXIFORCE force sensor from Tekscan (South Boston, Mass.) (see, e.g., U.S. Pat. No. 6,272,936). Any sensor, however, that is thin so as to provide non-intrusive measurement and capable of reliable positioning to the aid (e.g., an insole as described herein) may be used. In an aspect, the sensor measures a force over area that is circular having a diameter that is less than or equal to 10 cm, 8 cm, 5, cm, 1 cm, 0.8 cm, 0.5 cm or about 0.95 cm.

The aids and methods disclosed herein can use any number of sensors as desired. However, as the number of sensors increases, redundant and unnecessary measurements may be obtained. Accordingly, in an aspect, the number of sensors may be no more than 20, no more than 19, no more than 18, no more than 17, no more than 16, no more than 15, no more than 14, no more than 13, no more than 12, no more than 11, no more than 10, no more than 9, no more than 8, no more than 7, no more than 6, no more than 5, no more than 4, no more than 3, no more than 2, or no more than 1.

In some embodiments, each sensor may be configured to measure a respective signal at predetermined intervals. In an aspect, the data acquisition frequency may be about 20 Hz, from about 10 Hz to about 30 Hz, or selected based on the cadence of the subject, so that data acquisition occurs at least twice during the range of a walking, running, or pedal motion, for example. Under different conditions and users, a pedaling cadence, for example, may range from 50 rpm to about 120 rpm. In an aspect, the acquisition may be periodically turned on and then turned off to ensure data is sampled over the entire walking, running, pedaling, resting, or lying down exercise, for example.

In some embodiments, a data storage may be operatively coupled to the sensor and configured to record the measured signal. The data storage may be used to store the measured signal locally or to a remote location, for storage and later analysis. In some embodiments, the data storage may include an SD card, a MicroSD card, and a universal serial bus (USB) device. In other embodiments, however, the system may not include the data storage.

The signal processor is operatively coupled to the sensors, and configured to determine a diagnosis based on the measured signal. In some embodiments, the signal processor may include a self-contained microcontroller (and associated components such as power supply, pressure sensors, wiring) capable of being used in the field, such as during a non-stationary bicycle ride outdoors. In contrast, a microcontroller that is not self-contained may not be portable for real-time use and remain in the testing facility where it is hooked into a computer or other data-recording/observing device. In some embodiments, the signal processor may include a Rabbit® 4000 microprocessor (see, e.g., www.digi.com/products/wireless-wired-embedded-solutions/software-microprocessors-accessories/systems-on-chip/rabbit4000#overview) that receives analog input from the sensors and converts them into digital signals to be stored in its memory. Other optional components may be included in the microcontroller as desired, including switches and LED to indicate sensor and/or recording status. For example, operational amplifiers may be included such as National Semiconductor LM324 low power quad operational simplifiers.

In some embodiments, the system includes a signal transmission network operatively coupled to the sensors and signal processor. The signal transmission network may be configured to transmit the signal according to at least one of a wired interface and ANT+, Bluetooth, ZigBee, WiFi, cellular access technologies (e.g., 2G, 3G, Universal mobile Telecommunications Systems (UMTS), GSM, Long Term Evolution (LTE), or more), etc. In other embodiments, one or more features of the insole as described herein (e.g., protrusions and roller) may be movable in response to the measured signal, thereby adjusting the discomfort felt by the user. Such movement of the protrusions and/or roller of the insole may be automated or manual.

(2) Cervical, Thoracic, and Lumbar Regions

The aid may contact or engage the target body portion of the user. The target body portion may be a cervical region, a thoracic region, a lumbar region, a portion thereof, or any combination thereof of the user. The aid may be back pad.

(a) Back Pad

The back pad may be adaptable to be placed or positioned between the user's clothing (e.g., shirt, pants, etc.) and one or more of the cervical, thoracic, and lumbar regions of the user. In other embodiments, the back pad may be positioned between a body support (e.g., couch, chair, bed, etc.) and one or more of the cervical, thoracic, and lumbar regions of the user.

The lower surface of the back pad may be located opposite the cervical, thoracic, and/or lumbar regions of the user and adjacent to the clothing or body support. The upper surface of the back pad may be placed or positioned adjacent to the cervical, thoracic, and/or lumbar regions of the user, and thus, the protrusions are positioned adjacent to the cervical, thoracic, and/or lumbar regions of the user. Accordingly, when the user places a load or weight on (or rotates) one or more of a cervical, thoracic, and lumbar region contacting the upper surface of the back pad, and thus the protrusions, the user feels discomfort because the protrusions impinge upon or depress the cervical, thoracic, and/or lumbar regions of the user. In other words, the protrusions are substantially not deformed by the weight (or rotation) applied by the user, and therefore, push (or exert force) against the cervical, thoracic, and/or lumbar regions of the user when the user places weight on (or rotates) a first portion of the cervical, thoracic, and/or lumbar regions in contact with the back pad. To avoid such discomfort, the user may shift or rotate their weight to a second portion of the cervical, thoracic, and/or lumbar regions not in contact with the back pad, i.e., the portion of the cervical, thoracic, and/or lumbar regions contralateral to the portion of the cervical, thoracic, and/or lumbar regions in contact with the back pad. Accordingly, the back pad may affect an altered posture or rotational symmetry in the user.

(3) Buttock

The aid may contact or engage the target body portion of the user. The target body portion may be a buttock of the user, and therefore, the aid may have a shape generally corresponding to a shape of the user's buttock or a portion thereof. Accordingly, the aid may be a butt pad.

(a) Butt Pad

The butt pad may be adaptable to be placed or positioned between the user's clothing (e.g., pants, underwear, etc.) and the buttock of the user. In other embodiments, the butt pad may be positioned between a body support (e.g., couch, chair, bed, etc.) and the buttock of the user.

The lower surface of the butt pad may be located opposite the buttock of the user and adjacent to the clothing or body support. The upper surface of the butt pad may be placed or positioned adjacent to the buttock of the user, and thus, the protrusions are positioned adjacent to the buttock of the user. Accordingly, when the user places a load or weight on the buttock contacting the upper surface of the butt pad, and thus the protrusions, the user feels discomfort because the protrusions impinge upon or depress the buttock of the user. In other words, the protrusions are substantially not deformed by the weight applied by the user, and therefore, push (or exert force) against the buttock of the user when the user places weight on the buttock in contact with the butt pad. To avoid such discomfort, the user may shift their weight to a buttock not in contact with the butt pad, i.e., the buttock contralateral to the buttock in contact with the butt pad. Accordingly, the butt pad may affect an altered posture or vertical alignment in the user.

3. METHOD OF TREATMENT

Also provided herein are methods of treatment utilizing the aids disclosed herein. The methods may induce a physiologically desirable movement in the user or subject. Such methods may include providing the aid described above and contacting the first or target body portion of the subject with the aid for a period of time sufficient to modify the movement of the subject. Contacting may include positioning the protrusions adjacent to the first or target body portion of the subject.

As discussed above, modifying the movement of the subject may include the subject transferring or shifting weight from the first or target body portion of the subject to the second or contralateral body portion of the subject. In other words, the first body portion is contralateral to the second body portion to which weight is to be shifted.

The subject may be suffering from a musculoskeletal impairment, a neurological impairment, or a combination thereof. The musculoskeletal impairment may be scoliosis. The neurological impairment may be pushers syndrome or a stroke. The stroke may be a unilateral stroke. The unilateral stroke may result in paresis of one or more body portions of the subject, for example, a foot, sole, buttock, leg, and/or arm of the subject. The paresis may be monoparesis, i.e., affecting one leg or arm of the subject, and therefore, the subject may have a paretic limb or body portion and a non-paretic limb or body portion. The non-paretic and paretic body portions may be contralateral to one another.

When the paretic body portion is a leg and/or foot of the user, the paretic body portion may contribute to gait asymmetry. Particularly, the methods may treat a subject suffering from gait asymmetry when the aid is an insole as described above. Such methods may include providing the insole and contacting the first or target body portion of the subject with the insole for a period of time sufficient to modify the gait of the subject.

The method may also include positioning the insole in footwear of the subject. The footwear may be a sandal, a shoe, a sock, and the like. The method may further include replacing the insole with a second insole and contacting the first or target body portion of the subject with the second insole for a period of time sufficient to modify the gait of the subject. The protrusions of the second insole may have a height greater than a height of the protrusions of the first insole. Alternatively, any number of features or parameters, for example, a height of the protrusions, a thickness of the insole, a length dimension of the insole, an arrangement or pattern of the protrusions on the upper surface of the insole, and combinations thereof, may differ between the first and second insoles as described in more detail below. The first or target body portion may be a non-paretic sole of the subject. The subject may have had a unilateral stroke. The first or target body portion may be a paretic sole of a subject suffering from pushers syndrome.

a. Period of Time

The time period may be include a plurality of or multiple discrete time periods. Each discrete time period may be 5 minutes, 10 minutes, 20 minutes, 40 minutes, 60 minutes, 80 minutes, 100 minutes, or 120 minutes. The multiple discrete time periods may be one time period per week for one week, two weeks, three weeks, four weeks, five weeks, six weeks, seven weeks, or eight weeks. The multiple discrete time periods may be two time periods per week for one week, two weeks, three weeks, four weeks, five weeks, six weeks, seven weeks, or eight weeks. The multiple discrete time periods may be three time periods per week for one week, two weeks, three weeks, four weeks, five weeks, six weeks, seven weeks, or eight weeks. The multiple discrete time periods may be four time periods per week for one week, two weeks, three weeks, four weeks, five weeks, six weeks, seven weeks, or eight weeks. The multiple discrete time periods may be five time periods per week for one week, two weeks, three weeks, four weeks, five weeks, six weeks, seven weeks, or eight weeks. The multiple discrete time periods may be six time periods per week for one week, two weeks, three weeks, four weeks, five weeks, six weeks, seven weeks, or eight weeks. The multiple discrete time periods may be seven time periods per week for one week, two weeks, three weeks, four weeks, five weeks, six weeks, seven weeks, or eight weeks. The multiple discrete time periods may also be any combination of the above described embodiments of the multiple discrete time periods.

4. KITS

Also provided herein are kits for use with the methods disclosed herein. The kits may include a plurality of or multiple aids. The aid may be an insole, a back pad, or a butt pad as described above. The multiple aids may be multiple insoles. The multiple insoles may include a first insole, a second insole, a third insole, and so forth. Any number of parameters or features of the insoles may vary between each insole, for example, a height of the protrusions, a thickness of the insole, a length dimension of the insole, an arrangement or pattern of the protrusions on the upper surface of the insole, and combinations thereof.

In some embodiments, a height of the protrusions of the first insole may be smaller than a height of the protrusions of the second insole. The height of the protrusions of the second insole may be smaller than a height of the protrusions of the third insole. Accordingly, the height of the protrusions of the first insole may be smaller than the height of the protrusions of the third insole. Alternatively, the respective heights of the protrusions of the first, second, and third insoles may be substantially equivalent to one another.

In other embodiments, the respective heights of the protrusions of the first and second insoles may be substantially equivalent, but the height of the protrusions of the third insole may be smaller or greater than the heights of the protrusions of the first and second insoles. In still other embodiments, the respective heights of the protrusions of the first and third insoles may be substantially equivalent, but the height of the protrusions of the second insole may be smaller or greater than the heights of the protrusions of the first and third insoles. In yet still other embodiments, the respective heights of the protrusions of the second and third insoles may be substantially equivalent, but the height of the protrusions of the first insole may be smaller or greater than the heights of the protrusions of the second and third insoles.

In some embodiments, a thickness of the first insole may be smaller than a thickness of the second insole. The thickness of the second insole may be smaller than a thickness of the third insole. Accordingly, the thickness of the first insole may be smaller than the thickness of the third insole. In still other embodiments, the respective thickness of the first, second, and third insoles may be substantially equivalent to one another.

In other embodiments, the respective thicknesses of the first and second insoles may be substantially equivalent, but the thickness of the third insole may be smaller or greater than the thicknesses of the first and second insoles. In still other embodiments, the respective thicknesses of the first and third insoles may be substantially equivalent, but the thickness of the second insole may be smaller or greater than the thicknesses of the first and third insoles. In yet still other embodiments, the respective thicknesses of the second and third insoles may be substantially equivalent, but the thickness of the first insole may be smaller or greater than thicknesses of the second and third insoles.

In some embodiments, a length dimension of the first insole may be substantially equivalent to a length dimension of the second insole. The length dimension of the second insole may be substantially equivalent to a length dimension of the third insole. Accordingly, the length dimension of the first insole may be substantially equivalent to the length dimension of the third insole.

In still other embodiments, the length dimension of the first insole may be smaller than the length dimension of the second insole, and the length dimension of the second insole may be smaller than the length dimension of the third insole. Accordingly, the length dimension of the first insole may be smaller than the length dimension of the third insole.

In other embodiments, the respective length dimensions of the first and second insoles may be substantially equivalent, but the length dimension of the third insole may be smaller or greater than the length dimensions of the first and second insoles. In still other embodiments, the respective length dimensions of the first and third insoles may be substantially equivalent, but the length dimension of the second insole may be smaller or greater than the length dimensions of the first and third insoles. In yet other embodiments, the respective length dimensions of the second and third insoles may be substantially equivalent, but the length dimension of the first insole may be smaller or greater than the length dimensions of the second and third insoles.

In some embodiments, the protrusions of the first insole may be arranged in a first pattern, the protrusions of the second insole may be arranged in a second pattern, and the protrusions of the third insole may be arranged in a third pattern. Various patterns of the protrusions are described above. The first, second, and third patterns may be substantially equivalent in appearance. Alternatively, the first and second patterns may be substantially equivalent in appearance, but the third pattern may be substantially different in appearance from the first and second patterns. In still other alternative embodiments, the first and third patterns may be substantially equivalent in appearance, but the second pattern may be substantially different in appearance from the first and third patterns. In other alternative embodiments, the second and third patterns may be substantially equivalent in appearance, but the first pattern may be substantially different in appearance from the second and third patterns. In other embodiments, the first, second, and third patterns may be substantially different in appearance from one another.

The insoles of the kit may incorporate any combination of features or parameters as described in the above embodiments. As a non-limiting example, the respective heights of the protrusions of the first and second insoles may be equivalent, but the thickness of the first insole may be smaller than the thickness of the second insole, while the height of the protrusions of the third insole may be greater than the heights of the protrusions of the first and second insoles, and the thickness of the third insole may be substantially equivalent to the thickness of the second insole.

The present invention has multiple aspects, illustrated by the following non-limiting examples.

3. EXAMPLES Example 1 Materials and Methods for Examples 2-9

Healthy Subjects.

Eleven healthy, young subjects were included in the study. Six were females and five were males. The mean age of these subjects was 28.0±4.1 years. Ten of the eleven subjects participated in the static and dynamic balance assessments conducted with the EQUITEST system described in more detail below.

Subjects with Stroke.

A pilot experiment was also conducted that involved four subjects with unilateral chronic stroke. The four subjects had asymmetrical stance and gait. Three subjects were females and one subject was male. The mean age of the subjects with stroke was 51.2±8.6 years and the time from stroke onset was 2.5±0.4 years.

Insole.

The insole was made of polypropylene and included small, pyramidal peaks having a height of 2 mm to 3 mm. The distance from a center of one peak to a center of a second, adjacent peak was approximately 10 mm. The total height of the insole was about 4 mm to 6 mm. A limb of the subject provided or contacted with the insole was a target limb while the other limb was a contralateral limb. For the subjects with stroke, the insole was positioned in the shoe on the unaffected (or non-paretic) side to examine whether the insole improved the symmetry of gait, and thus, increased the time the affected (i.e., paretic or contralateral) side or limb contacted the ground (i.e., increased load or weight bearing of the affected limb).

Instrumentation and Procedure.

The subjects were assessed with regards to static weight bearing, dynamic balance control, and gait. Each subject was assessed wearing standard sandals with and without the insole in the below described tests. Specifically, there were three experimental conditions: (1) no insole was positioned in either sandal (i.e., no insole); (2) the insole was positioned in the right sandal (i.e., right insole); and (3) the insole was positioned in the left sandal (i.e., left insole). Three trials were recorded for each experimental condition.

Balance was evaluated using the SMART EQUITEST system (NeuroCom International Inc., OR), which provided an objective assessment of balance control and postural stability under static and dynamic test conditions. Such static and dynamic test conditions reflect the challenges of daily life, and each subject was tested while standing on the platform of the EQUITEST system. The EQUITEST system has high test/retest reliability for assessing balance. Specifically, a weight bearing (WB) test assessed the percentage of body weight borne by each leg during four trials of erect, quiet stance while a motor control test (MCT) assessed the ability of the subjects to quickly recover following an unexpected external disturbance. Sequences of small, medium, and large platform translations in forward and backward directions were used while the subjects stood fitted in a safety harness. Three trials were performed for each magnitude (i.e., small, medium, and large) of platform translation in both the forward and backward directions. Three parameters were obtained from the MCT: (1) dynamic weight bearing symmetry (WS), which quantified the weight borne on each leg during platform translation; (2) latency, which quantified the time between translation (i.e., stimulus) onset and initiation of the subject's active response (i.e., the force response in each leg); and (3) strength symmetry, which quantified the strength of the responses for both legs.

Gait was assessed using the GAITRITE system (CIR Systems, Inc. Havertown, Pa.), which allowed for measurements of the temporal and spatial characteristics of gait. The GAITRITE system is a walkway containing a series of sensor pads encapsulated in a carpet having dimensions 457 cm long and 90 cm wide. The walkway has an active measurement area of 366×61 cm. The sensors are arranged in a grid pattern with a total of 13,824 sensors placed 1.27 cm apart from another. The sensors are activated by mechanical pressure from contact with the feet of a subject. Data from the activated sensors was collected by a computer with a sampling rate of 80 Hz and automatic footstep identification and parameter calculation was done. The GAITRITE system has high reliability and validity for assessing gait. The GAITRITE walkway was positioned in a hallway such that a subject started walking about one meter prior to stepping on the walkway of the GAITRITE system, and continued walking one meter past the end of the walkway. Each subject was instructed to walk at a self-selected comfortable speed.

Data Analysis.

For the weight bearing test, the percent weight bearing (% WB) on each leg was calculated as an average of four trials for each experimental condition (i.e., no insole, right insole, and left insole). Weight symmetry scores, response latencies, and strength symmetry scores were calculated by the EquiTest computer software and were based on a differentiation of force plate data from each foot.

Weight symmetry (WS) reflected how much of the subject's weight is carried by each leg during the support surface translation trials. Each symmetry measurement represented the average of the results from three medium and large translation trials. Weight symmetry was calculated by the following formula: W=(RF+RR)/(LF+LR+RF+RR)×200. RF and RR are the vertical forces measured by the right front and rear force cells, respectively. LF and LR are the vertical forces measured by the left front and rear force cells, respectively. When both legs carried equal weight, RF+RR equaled LF+LR, and the weight symmetry score was 100. When the right leg carried more weight, the score was greater than 100. When the left leg carried more weight, the score was less than 100.

Response latency or latency was defined as the time in milliseconds (ms) between the onset of a translation and the onset of the subject's active response to the support surface movement. Strength symmetry was calculated from the slope of the force curve during the active force response and indicated the symmetry of the relative response strength for each foot. In healthy subjects, the response strength scores from the right and left legs were approximately equal in amplitude, and thus, the strength symmetry was 100.

The durations of the single support phase, swing phase, and stance phases were calculated for each leg as a percentage of the gait cycle using the GaitRite software. In addition, for each obtained gait variable, a symmetry index (SI_(Vi)) was calculated as follows:

SI _(Vi)=(V _(contralateral) −V _(target))/(½×(V _(contralateral) +V _(target)))×100

V_(target) was the corresponding variable for the limb provided with the insole and V_(contralateral) was a gait variable recorded for the contralateral limb (i.e., the limb that was not provided with the insole). A SI=0 represented perfect symmetry. A positive (+) SI indicated a larger magnitude of the particular variable on the contralateral limb, while a negative (−) SI denoted a smaller magnitude on the target limb.

Multiple repeated-measures ANOVAs were performed and included two within subject factors: (1) insole condition (i.e., no insole, right insole, and left insole) and (2) side of the subject (i.e., right and left sides). The first analysis was focused on balance and the dependent variables were percent of weight bearing, weight symmetry, latency, and strength symmetry. For the MCT, direction of platform translation (i.e., forward and backward translation) was also included as a within subject factor for analysis.

The second analysis was focused on gait and the dependent variables were the duration of the single support, swing phase, stance phase, and SI. A post hoc analysis (pair-wise t-test) with Bonferroni correction was performed to compare between conditions. For all the tests, statistical significance was set at p<0.05. Statistical analysis was performed in SPSS 17 for Windows 7 (SPSS Inc., Chicago, USA).

Example 2 Weight Bearing of Healthy Subjects Under Static Condition

The weight bearing of healthy subjects that used the insole was affected under the static condition. During quiet standing with no insole, weight bearing measured as a percentage of the total body weight (% WB) was 50.6±1.97% and 49.39±1.97% on the left and right sides of the subjects' bodies, respectively. The difference between the left and right sides was not statistically significant (p=0.61). The % WB, however, increased on the left side of the body when the insole was placed in the right sandal, and the % WB increased on the right side of the body when the insole was placed in the left sandal (FIG. 8). ANOVA revealed significant side-insole interaction for the % WB (F_(10,2)=50.44, p<0.001) with post-hoc comparisons being significant for conditions with insole (p<0.05). Accordingly, the discomfort or negative feedback provided by the peaks of the insole caused the subjects to increase weight bearing on the limb or side not contacting the insole (i.e., the contralateral limb or side) and thus, decrease weight bearing on the limb or side contacting the insole (i.e., the target limb or side).

Example 3 Weight Symmetry of Healthy Subjects Under Dynamic Condition

The weight symmetry (WS) of healthy subjects that used the insole was affected under dynamic conditions, and the effect of the insole was statistically significant during the dynamic tests. In the dynamic test, WS=100 referred to both legs carrying equal weight. WS greater than 100 reflected that the right leg carried more weight. WS less than 100 signified that the left leg carried more weight.

When the subjects were standing with no insole, the dynamic weight symmetry index (WS) was 99.46±0.33 across the conditions with different magnitude (i.e., small, medium, and large) and direction (i.e., forward and backward) of the platform translations (Table 1, mean±standard deviation (SD) is shown).

TABLE 1 Weight Symmetry (WS) Indices Significance No Insole Right Insole Left Insole (p value) Backward Small 99.25 ± 9.59  68.5 ± 26.66 129.88 ± 26.54  <0.001 Translations Medium 99.50 ± 8.22 70.06 ± 22.99 132.2 ± 24.93 <0.001 Large 100.00 ± 8.81  68.30 ± 24.36  131 ± 21.15 <0.001 Forward Small 99.50 ± 9.13 71.25 ± 27.59  134 ± 27.27 <0.001 Translations Medium 99.00 ± 7.87  68.8 ± 27.87 133.8 ± 26.84 <0.001 Large 99.60 ± 8.44  69.0 ± 26.21 131.20 ± 24.76  <0.001

When the insole was placed in the right sandal, the WS index was 69.30±1.13, revealing that the left leg carried more weight. When the insole was placed in the left sandal, the WS index increased to 132.01±1.64, indicating that more weight was carried by the right leg. The effect of the insole was statistically significant for the large (F_(9,2)=47.3, p<0.001), medium (F_(9,2)=43.8, p<0.001), and small (F_(9,2)=30.2, p<0.001) perturbations. Accordingly, the discomfort or negative feedback provided by the peaks of the insole caused the subjects to increase weight bearing on the limb or side not contacting the insole (i.e., the contralateral limb or side) and thus, decrease weight bearing on the limb or side contacting the insole (i.e., the target limb or side).

Example 4 Strength Symmetry of Healthy Subjects Under Dynamic Condition

The strength symmetry (SS) of the healthy subjects that used the insole was affected under dynamic conditions, and the effect of the insole was statistically significant during the dynamic tests. In the dynamic test, a SS=100 referred to the equal strength of the responses produced by both of the legs.

When no insole was placed in either the right or left sandal, strength symmetry across all the directions (i.e., forward and backward) and magnitudes (i.e., small, medium, and large) of perturbations was 102.25±5.5 (Table 2, mean±standard deviation (SD) is shown).

TABLE 2 Strength Symmetry (SS) Indices Significance No Insole Right Insole Left Insole (p value) Backward Small  96.75 ± 18.84 49.88 ± 22.13 145.00 ± 47.21 <0.001 Translations Medium 102.67 ± 19.70 59.33 ± 40.55 148.25 ± 28.27 <0.001 Large 102.80 ± 16.12 62.10 ± 24.69 147.30 ± 24.70 <0.001 Forward Small 110.25 ± 43.43 67.25 ± 21.96 140.25 ± 21.43 <0.001 Translations Medium 101.00 ± 10.36 77.60 ± 23.43 135.40 ± 20.35 <0.001 Large 100.00 ± 12.28 75.50 ± 18.17 124.50 ± 21.16 <0.001

When the insole was placed in the right sandal, the strength symmetry of the response shifted to the left leg (strength symmetry 65.28±10.4). When the insole was placed in the left sandal, strength symmetry of the response shifted to the right leg (strength symmetry 140±9.0). The effect of the insole was statistically significant for large perturbations (F_(9,2)=58.65, p<0.001), medium perturbations (F_(9,2)=41.92, p<0.001), and small perturbations (F_(9,2)=28.79, p<0.001). ANOVA also revealed significant side-insole interaction for the large perturbations (F_(9,2)=3.56, p<0.05). Accordingly, the discomfort or negative feedback provided by the peaks of the insole caused the subjects to increase the response strength on the limb or side not contacting the insole (i.e., the contralateral limb or side) and thus, decrease the response strength on the limb or side contacting the insole (i.e., the target limb or side).

Example 5 Latency of Healthy Subjects Under Dynamic Condition

The latency of the healthy subjects was examined under dynamic conditions in the absence and presence of the insole. When the subjects were exposed to sudden platform translations with no insole, the latencies on the left and right sides were comparable. When the insole was placed in the right sandal, the latency of the left leg became smaller and the latency of the right leg became larger. When the insole was placed in the left sandal, the latency decreased on the right side and increased on the left side. These results were observed with both directions (i.e., forward and backward) and with the three magnitudes (i.e., small, medium, and large) of the platform translations (FIG. 9). The differences or changes in latency on each side, however, were not statistically significant. Accordingly, to avoid the discomfort or negative feedback provided by the peaks of the insole, the subject tended to decrease or delay the response of the contralateral limb (i.e., limb or side not in contact with the insole) as compared to the no insole condition and to produce an early response of the target limb (i.e., the limb or side in contact with the insole) as compared to the no insole condition.

Example 6 Gait Velocity of Healthy Subjects

The gait velocity of healthy subjects was examined in the presence and absence of the insole. In the presence of the insole, gait velocity was measured when the insole was placed in either the right or left sandal of the subject. The gait velocity was 134.3±20.6 cm/sec when the subjects walked with no insole positioned in either the right or left sandals (i.e., no insole condition). When the subjects walked with the insole placed in the right sandal, the gait velocity was 127.0±19.7 cm/sec (i.e., right insole condition). The gait velocity was 127.11±17.9 cm/sec when the subjects walked with the insole positioned in the left sandal (i.e., left insole condition). The differences in gait velocity between the three conditions (i.e., no insole, right insole, and left insole) were not statistically significant (p=0.6).

Example 7 Gait Cycle Assessment of Healthy Subjects

The gait of healthy subjects was examined in the presence and absence of the insole. Specifically, the single support phase, swing phase, and stance phase of gait were examined using the GAITRITE system as described above in Example 1.

With regards to the single support phase, the duration of the single support phase of gait was similar between the left and right side of the subjects when no insole was placed in either the right or left sandals (FIG. 10A). When the insole was placed in the right sandal, the duration of the single support phase decreased on the right side and increased on the left side of the subjects. The duration of the single support phase, however, decreased on the left side and increased on the right side of the subjects when the insole was placed in the left sandal. ANOVA analysis revealed significant side-insole interaction for the single support phase of gait (F_(10,2)=18.8, p<0001) with post-hoc comparisons being significant for conditions with the insole (p<0.05). Additionally, significant side-insole interaction was also observed for the swing phase (F_(10,2)=15.3, p<0001) and stance phase of gait (F_(10,2)=16.6, p<0001) (FIGS. 10B and 10C).

Pair-wise comparison revealed that the difference in each of the three gait parameters (i.e., single support, swing, and stance phases) measured on the left and right side of the body was seen only when the subjects were walking with the insole. Accordingly, the insole affected a change in the gait of the healthy subjects by altering the symmetry of the subjects' gait.

The symmetry indices (SI) for single support, stance, and swing phases as percentages of the gait cycle are shown in Table 3, in which mean±standard deviation (SD) is shown. A SI=0 represented perfect symmetry. A negative (−) sign denoted longer single support and stance time on the side contralateral to the side in contact with the insole. The negative (−) sign also denoted shorter swing durations on the side contralateral to the side in contact with the insole.

While walking with no insole, the SI indices for the single support, stance, and swing phases of gait were close to 0, indicating almost perfect symmetry. When the insole was provided in either the right or left sandals, the gait became asymmetrical, which is shown by the increased or decreased SI indices.

TABLE 3 Symmetry Indices (SI) in Healthy Subjects Parameter No Insole Right Insole Left Insole Single Support Phase  1.88 ± 2.29 13.07 ± 10.40 −8.47 ± 7.48 Stance Phase −0.13 ± 1.48 6.35 ± 5.17 −4.83 ± 4.57 Swing Phase −0.13 ± 1.48 −11.58 ± 9.48   9.04 ± 8.13

Example 8 Gait Velocity and Gait Cycle Assessment in Subjects with Unilateral Stroke

Individuals with unilateral stroke often exhibit gait asymmetry because less weight or load is placed on the affected or paretic limb or side. Accordingly, the gait velocity and parameters of gait cycle (i.e., single support, stance, and swing phases) of subjects with unilateral stroke were examined to determine if the insole altered or improved gait velocity and gait symmetry in the same subjects. Specifically, the gait velocity was measured while the subjects walked with or without the insole, which was placed in the sandal of the non-paretic limb when used. Analysis showed that the subjects exhibited similar gait velocities while walking with or without the insole (p=0.69).

The gait cycle of the subjects was also examined in the presence and absence of the insole. Specifically, the single support phase, swing phase, and stance phase of gait were examined using the GAITRITE system as described above in Example 1.

The gait of the subjects was first measured without the insole (i.e., no insole) and was asymmetrical as shown by the negative (−) SI indices (Table 4, mean±standard deviation (SD) is shown). These negative SI indices for the single support and stance phases of gait indicated a shorter single support and stance time on the affected (i.e., paretic) limb relative to the unaffected (i.e., non-paretic) limb. These negative SI indices also indicated a prolonged swing time on the affected limb relative to the unaffected limb.

The gait of the subjects was then measured in the presence of the insole, and the asymmetry of gait was decreased with use of the insole (Table 4) as indicated by the values for single support, stance, and swing time moving closer to 0. A SI=0 represented perfect symmetry. Accordingly, the insole caused a decrease in gait asymmetry for the subjects suffering with unilateral stroke in a single session or period of time.

TABLE 4 Symmetry Indices (SI) in Subjects with Unilateral Stroke Parameter No Insole Insole Single Support Phase −70.79 ± 18.87 −51.27 ± 25.42 Stance Phase −47.23 ± 13.88 −32.75 ± 11.74 Swing Phase  67.33 ± 26.82  58.38 ± 20.62

Example 9 Effect of Multiple Treatment Sessions with Insole for a Subject Suffering from Stroke

Individuals with unilateral stroke often exhibit gait asymmetry because less weight or load is placed on the affected or paretic limb or side. Accordingly, the single support and stance phases of gait were examined in a subject suffering from stroke and receiving multiple treatment sessions with the insole. The duration of the single support phase was measured as a percentage of the gait cycle. Gait was measured twice without the insole. The first measurement was prior to the start of the treatment sessions (i.e., “before” in FIG. 11) and the second measurement was after the end of the treatment sessions (i.e., “after” in FIG. 11). The treatment included 3 sessions per week for a total of 8 sessions. In each session, the insole was place in the left sandal of the subject, which corresponded to the unaffected or non-paretic side or limb of the subject. The patient tolerated the treatment sessions well.

As shown in FIG. 11 (solid arrow), the duration of the single support time decreased on the left side of the subject (i.e., the unaffected or non-paretic side or limb) after completion of the treatment sessions as compared to before beginning the treatment sessions. The duration of the single support time increased on the right side of the subject (i.e., the affected or paretic side or limb) after completion of the treatment sessions as compared to before beginning the treatment sessions (FIG. 11, dashed arrow). Additionally, the symmetry index (SI) for stance improved from −31.39 to −21.92. The SI for single support improved from −61.54 to −36.60. An SI=0 represented perfect symmetry. Accordingly, the multiple treatment sessions with the insole affected a change in the gait of the subject, namely improving the symmetry of the gait as demonstrated by the SI value moving closer to 0.

The treatment sessions with the insole altered the subject's gait, in which such an alteration improved the symmetry of the subject's gait. Furthermore, this improvement was measurable in the absence of the insole (i.e., after completion of the training sessions), indicating that the insole affected a change in gait symmetry and that such a change was maintained after removal of the insole from the subject's sandal. In other words, the subject was trained or learned to alter their gait via use of the insole and was able to utilize such training to maintain the improved gait symmetry.

Example 10 Effect of Multiple Treatment Sessions with Multiple Insoles in Subjects Suffering from Stroke

The single support, stance, and swing phases of the gait cycle are measured in subjects suffering from unilateral stroke before, during, and after the treatment sessions with the insole. Specifically, the single support, stance, and swing phases of the gait cycle are measured for each subject before beginning the treatment sessions, in which no insole is placed in either sandal of the subjects.

For the treatment sessions, the insole is placed in the sandal corresponding to the unaffected or non-paretic limb of each subject. The treatment includes 3-5 sessions per week for 6 weeks. During treatment, single support, stance and swing phases are measured in the absence of the insole for each subject after completion of each week of the treatment. If the symmetry of the gait is improved, the same insole is used in the subsequent sessions of the following week. If the symmetry of the gait is not improved (or slightly improved), a different insole is used in the subsequent sessions of the following week. For example, the different insole may have peaks with a greater height to increase the discomfort felt by the subject in the unaffected limb, thereby causing the subject to increase the amount of time the affected limb is in contact with the ground (i.e., bearing weight). Accordingly, an individual supervising or managing the treatment sessions can select from a variety of insoles having different properties (i.e., thickness, pattern of peaks, location of peaks, peak height, etc.) to adapt treatment to the individual needs of each subject.

Upon completion of the treatment sessions, it is expected that the gait symmetry of the subjects, including those subjects in which two or more insoles are required during treatment, will be significantly improved. The subjects' will be able to exhibit improved gait symmetry after completion of the treatment sessions and in the absence of the insole as measured by the symmetry indices (SI) of single support, stance, and swing moving closer to 0, in which an SI=0 indicates perfect symmetry.

Furthermore, it is expected that the gait symmetry of the subjects, including those subjects in which two or more insoles are required during treatment, will be significantly improved long-term (e.g., 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, and so forth) after completion of the treatments sessions. After completion of the treatment sessions, no insole is used by the subjects. In other words, it is expected that the subjects will retain the improved gait symmetry afforded by the treatment sessions with the insole, and such retention is tested by measuring the gait symmetry of the subjects in the absence of the insole. The retention testing is done at a time point after completion of the treatment sessions, for example, 4 months after completion of the treatment sessions. It is expected that the retention testing will demonstrate the SI of single support, stance, and swing being closer to 0 than before the onset of the treatment sessions, and therefore, will demonstrate that the subjects have retained the improved gait symmetry afforded by the treatment sessions with the insole.

It is understood that the foregoing detailed description and accompanying examples are merely illustrative and are not to be taken as limitations upon the scope of the invention, which is defined solely by the appended claims and their equivalents.

Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art. Such changes and modifications, including without limitation those relating to the chemical structures, substituents, derivatives, intermediates, syntheses, compositions, formulations, or methods of use of the invention, may be made without departing from the spirit and scope thereof. 

What is claimed is:
 1. An aid for inducing a physiologically desirable movement, the aid comprising (a) upper and lower surfaces, defining therebetween a thickness of the aid, and (b) a plurality of protrusions extending from the upper surface of the aid and capable of engaging a body portion of a user for inducing discomfort in the body portion.
 2. The aid of claim 1, wherein the protrusions have a shape selected from the group consisting of a pyramidal shape, a spherical shape, a circular shape, an elliptical shape, a trapezoidal shape, a cylindrical shape, a rectangular shape, a square shape, a conical shape, and an irregular shape, and wherein the protrusions have a height of about 2 mm to about 10 mm.
 3. The aid of claim 1, wherein the thickness of the aid is uniform, and wherein the thickness of the aid is about 1 mm to about 10 mm.
 4. The aid of claim 1, wherein the aid is selected from an insole, a back pad, and a butt pad.
 5. The aid of claim 4, wherein the aid is an insole including (a) a toe end and a heel end, defining therebetween a length dimension of the insole.
 6. The aid of claim 5, wherein the protrusions are arranged in rows extending at least partially in the length dimension of the insole.
 7. The aid of claim 5, wherein a first of the protrusions is spaced from a second of the protrusions, defining therebetween a distance, and wherein the distance is about 10 mm.
 8. The aid of claim 5, wherein the insole is adaptable to be positioned in footwear, and wherein the footwear is selected from the group consisting of a sandal, a shoe, and a sock.
 9. The aid of claim 5, wherein the body portion is a foot of the user, wherein a hallux and a heel of the foot define therebetween a length dimension of the foot, and wherein the length dimension of the insole is substantially equivalent to the length dimension of the foot of the user.
 10. The aid of claim 1, wherein each protrusion includes (a) a distal end located opposite the upper surface of the aid and having a cross-sectional shape with a first area, and (b) a proximal end located adjacent to the upper surface of the aid and having a cross-sectional shape with a second area, wherein the first area is smaller than the second area.
 11. The aid of claim 1, wherein each protrusion is conical with an apex located opposite the upper surface of the aid, and wherein the apex is engageable with the body portion of the user.
 12. A method for treating a subject suffering from gait asymmetry, the method comprising: (a) providing an insole including (i) upper and lower surfaces, defining therebetween a thickness of the insole, (ii) a toe end and a heel end, defining therebetween a length dimension of the insole, and (iii) a plurality of protrusions extending from the upper surface of the insole and engagable with a body portion of the subject for inducing discomfort in the body portion; and (b) contacting the body portion of the subject with the insole for a period of time sufficient to modify the gait of the subject.
 13. The method of claim 12, wherein the subject had a stroke.
 14. The method of claim 13, wherein the stroke is a unilateral stroke, and wherein the body portion is a non-paretic sole of the subject.
 15. The method of claim 12, wherein the protrusions extend from at least one of a toe region, an arch region, and a heel region of the insole.
 16. The method of claim 12, wherein the period of time includes a plurality of discrete time periods.
 17. The method of claim 12, further comprising positioning the insole in footwear of the subject, and wherein the footwear is selected from the group consisting of a sandal, a shoe, and a sock.
 18. The method of claim 12, further comprising (a) replacing the insole with a second insole, wherein the second insole comprises (i) upper and lower surfaces, defining therebetween a thickness of the second insole, (ii) a toe end and a heel end, defining therebetween a length dimension of the second insole, and (iii) a plurality of protrusions extending from the upper surface of the second insole and engagable with the body portion of the subject for inducing discomfort in the body portion; and (b) contacting the body portion of the subject with the second insole for a period of time sufficient to modify the gait of the subject, wherein the protrusions of the second insole have a height greater than a height of the protrusions of the first insole.
 19. A method for inducing a physiologically desirable movement, the method comprising: (a) providing the aid of claim 1; and (b) contacting a first body portion of the subject with the aid for a period of time sufficient to modify the movement of the subject, wherein the first body portion is contralateral to a second body portion to which weight is to be shifted.
 20. The method of claim 19, wherein the subject is suffering from at least one of a musculoskeletal impairment and a neurological impairment.
 21. The method of claim 20, wherein the neurological impairment is selected from the group consisting of a stroke and a unilateral stroke.
 22. The method of claim 21, wherein the neurological impairment is a unilateral stroke, and wherein the first body portion is a non-paretic body portion of the subject.
 23. The method of claim 19, wherein contacting includes positioning the protrusions adjacent to the first body portion of the subject.
 24. The method of claim 19, wherein the period of time includes a plurality of discrete time periods.
 25. A kit comprising: (a) a plurality of insoles, each insole including (i) upper and lower surfaces, defining therebetween a thickness of the respective insole, and (ii) protrusions extending from the upper surface and engageable with a body portion of a subject for inducing discomfort in the body portion.
 26. The kit of claim 25, wherein the aid is an insole comprising a toe end and a heel end, defining therebetween a length dimension of the insole.
 27. The kit of claim 26, wherein a height of the protrusions of a first insole are smaller than a height of the protrusions of a second insole.
 28. The kit of claim 26, wherein the thickness of a first insole is smaller than the thickness of a second insole.
 29. The kit of claim 26, wherein the length dimension of a first insole is substantially equivalent to the length dimension of a second insole.
 30. The kit of claim 25, wherein the subject had a stroke, and wherein the body portion is a non-paretic body portion of the subject.
 31. The kit of claim 25, wherein the protrusions of a first aid are arranged in a first pattern and the protrusions of a second aid are arranged in a second pattern, and wherein the first and second patterns are substantially different from one another.
 32. The kit of claim 26, wherein the insoles are adaptable to be positioned in footwear, and wherein the footwear is selected from the group consisting of a sandal, a shoe, and a sock. 